Associate Director, GMP Quality Assurance

This is a fully remote position, open to applicants in California.

📋 Description

• Provide support for GMP CMC operations, which includes reviewing and approving manufacturer master and executed batch records, Certificates of Analysis, and related analytical data for GMP products intended for human clinical use.

• Assist in GMP/CMC Quality by Design (QbD), conduct risk assessments, and engage in process performance qualification (PPQ) and process validation activities.

• Collaborate closely with Qualified Persons (QPs) to certify and release drug products and final Investigational Medicinal Products (IMPs) for EU countries.

• Aid in the management and oversight of Erasca QA contractors who support GMP QA operations.

• Execute final product disposition.

• Review and approve Out of Specification (OOS) reports, deviations, product complaints, temperature excursions, corrective and preventive actions, and change controls prior to and/or after product release.

• Act as a liaison with internal subject matter experts and third-party/contract vendors.

• Provide quality oversight for clinical program supply requirements both domestically and internationally.

• Develop, review, and ensure compliance with quality agreements and customer contracts that contain quality-related information.

• Assist with internal and external compliance audits and vendor management activities.

• Support the selection and qualification of GMP vendors, representing Erasca Quality during Business Review Meetings.

• Serve as the Quality Assurance Person-in-Plant representative at Contract Manufacturers during the production of critical batches or campaigns as needed.

• Evaluate, author, and/or review operating procedures while supporting an integrated cross-functional quality management system.

• Collaborate with stakeholders and colleagues to establish metrics and report on the state of the Quality Management System.

• Fulfill duties in alignment with company values, policies, and relevant regulations.

• Report directly to the Executive Director of Quality Assurance GMP.

⛳️ Requirements

• Bachelor of Science in Biology, Chemistry, Physical Sciences, or a related degree, with training or an equivalent combination of education and experience in an FDA-regulated environment.

• Advanced degree in Pharmaceutics, Chemistry, or a related field, with 8+ years of progressive industry experience in pharmaceutical small molecule drug product development.

• At least 8-10 years of experience in a GxP pharmaceutical environment in progressively responsible Quality roles.

• A minimum of 8 years of GMP QA experience is highly desirable.

• Prior Quality oversight/support experience in solid oral dosage forms and biologics manufacturing is essential.

• Familiarity with electronic document management systems and Quality Management System software platforms is advantageous.

• Previous experience working with the FDA and participating in regulatory agency inspections is required.

• Experience with non-US regulatory agencies and/or international product supply is a plus.

• Strong interpersonal, verbal, and written communication skills.

• Ability to thrive in a fast-paced, team-oriented environment.

• Excellent organizational skills; capable of multitasking and shifting priorities as necessary.

• Strong learning orientation, curiosity, and a passion for science and patient care.

🏝️ Benefits

• Paid Time Off

• Holiday and Sick Leave

• Medical, Dental, and Vision Plans

• Short- and Long-Term Disability

• Basic and Voluntary Life/AD&D Coverage

• Flexible Spending Accounts (FSA, HSA, and Commute)

• Critical Illness and Accident Coverage

• Pet Insurance

• Employee Assistance Program

• 401(k) Plan with Erasca contribution

• Employee Stock Purchase Program

• Annual bonus

• Equity grant at hire and annually in the form of the option to purchase stock in the future

• Casual, collaborative, and enjoyable work environment